Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution , 100 mg/mL due to Crystallization

Company Contact:
Novartis Pharmaceuticals Corporation
1-888-669-6682

Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune ® Oral Solution (cyclosporine oral solution, USP), 100 mgmL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune formulations are impacted.

Sandimmune ^® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents ¹ .

Risk Statement: Crystallization of cyclosporine in Sandimmune Oral Solutionis likely to result in non-uniform distribution of the cyclosporine in the product, resulting in under-dosing or over-dosing. There is a reasonable probability that under-dosing may result in lower exposures and decrease in efficacy which could ultimately lead to graft rejection and graft loss in transplant patients. Furthermore, over-dosage may manifest itself as cyclosporine toxicity in the long term if over exposure continues. Novartis has not received any reports of adverse events related to this recall, to date.

The affected lot number and expiration date is: FX001691 (expiration date 12/2025). This lot was distributed nationwide to wholesalers across the US, beginning in April 2023 .

Novartis is notifying its distributors via a recall notification letter and is arranging for return of the recalled lot from distributors, retailers and consumers. Additionally, Novartis is notifying health care providers who have prescribed this product to contact their patients. Consumers that have bottles from the recalled lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100mg/mL, should contact their health care provider.

In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their health care provider and Novartis to report the event or finding. Patients or health care providers may call the Novartis customer interaction center at 888-NOW-NOVA (888-669-6682) from 8:30 AM - 5:00 PM ET Monday through Friday , or may report an adverse event through https://www.novartis.com/report or usdrugsafety.operations@novartis.com .

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online : www.fda.gov/medwatch/report.htm
Regular Mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is reimagining medicine to improve and extend people's lives. We deliver high-value medicines that alleviate society's greatest disease burdens through technology leadership in R&D and novel access approaches. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis employs about 14,000 people in the United States . For more information, please visit https://www.novartis.us

Novartis and Novartis US is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews and @NovartisUS at https://twitter.com/NovartisUS .

References

Sandimmune [prescribing information]. East Hanover, NJ : Novartis Pharmaceuticals Corporation; 2021.

# #

Novartis Media Relations E-mail: media.relations@novartis.com
North America Julie Masow		+1 862 579 8456
Michael Meo		+1 862 274 5414
Marlena Abdinoor		+1 617 335 9525
Novartis Investor Relations E-mail: investor.relations@novartis.com
North America Sloan Simpson	+1 862 778 5052

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SOURCE Novartis Pharmaceuticals Corporation

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Nevada Sunrise Initiates Data Review to Develop New Drill Targets at the Coronado Copper Project, Nevada

Nevada Sunrise Metals Corporation (TSXV: NEV) (OTCBB: NVSGF) ("Nevada Sunrise" or the "Company") is pleased to announce that the Company has initiated a geological and geophysical data review on its Coronado Copper Project (" Coronado ", or the " Project ") located in Pershing County, Nevada approximately 48 kilometers (30 miles) southeast of Winnemucca . The purpose of the Coronado data review is to identify new, shallow drill targets in an area of the Project where historical drilling in 1976 identified high-grade copper mineralization.

Highlights of the Coronado Copper Project

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Nevada Sunrise Signs Indicative Term Sheet to Sell Remaining Interest in the Kinsley Mountain Gold Project, Nevada

Nevada Sunrise Metals Corp. (TSXV: NEV) (OTCBB: NVSGF) ("Nevada Sunrise" or the "Company") announced today that it has signed a non-binding, indicative term sheet with CopAur Minerals Inc. (" CopAur ") for CopAur to acquire Nevada Sunrise's remaining ownership interest in the Kinsley Mountain Gold Project in Nevada (" Kinsley Mountain "). If the transaction is completed, CopAur will own 100% of Kinsley Mountain .

The indicative term sheet outlines a potential transaction whereby CopAur would acquire Nevada Sunrises' 18.74% ownership interest in Kinsley Mountain in consideration of the payment of CDN$475,000 and the issuance of 1,000,000 common shares of CopAur (the "Shares"). The Shares would be deposited in escrow and released in successive releases of 250,000 Shares once every calendar quarter commencing after expiry of the four-month statutory hold period following the closing date. The terms of the transaction are indicative and the final terms are subject to the negotiation and completion of a definitive agreement on terms acceptable to Nevada Sunrise and CopAur. The transaction is subject to a number of conditions including CopAur arranging a financing in the amount of a minimum of CDN$475,000 , completion of satisfactory due diligence, and the fulfilment of various closing conditions, including acceptance by the TSX Venture Exchange.

About Kinsley Mountain

Kinsley Mountain was a historical past producer that yielded 138,000 ounces of near-surface, open-pit oxide gold between 1995 and 1999, and currently hosts a compliant National Instrument 43-101 mineral resource. A technical report on Kinsley Mountain entitled "Technical Report of the Kinsley Project, Elko and White Pine Counties, Nevada, U.S.A. ", dated June 21, 2021 , with an effective date of May 5, 2021 , prepared by Michael M. Gustin and Gary L. Simmons , is available for review under New Placer Dome Gold Corp.'s issuer profile on sedarplus.ca

About Nevada Sunrise

Nevada Sunrise is a junior mineral exploration company with a strong technical team based in Vancouver, BC , Canada , that holds interests in lithium, gold and copper exploration projects located in the State of Nevada, USA .

Nevada Sunrise owns 100% interests in the Gemini, Jackson Wash and Badlands lithium projects, all of which are located in the Lida Valley in Esmeralda County, NV , and in the Pelican lithium project in Saskatchewan, Canada . The Company owns Nevada Water Right Permit 86863, also located in the Lida Valley basin, near Gold Point, NV.

Nevada Sunrise has the right to earn a 100% interest in the Coronado Copper Project , located approximately 48 kilometers (30 miles) southeast of Winnemucca, NV.

The Company owns an 18.74% interest in the Kinsley Mountain Gold Project near Wendover, NV , in a joint venture with CopAur, which is now the subject of a potential transaction between Nevada Sunrise and CopAur.

FORWARD LOOKING STATEMENTS

This release may contain forward–looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur and include disclosure of anticipated exploration activities. Although the Company believes the expectations expressed in such forward–looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in forward looking statements. Forward–looking statements are based on the beliefs, estimates and opinions of the Company's management on the date such statements were made. The Company expressly disclaims any intention or obligation to update or revise any forward–looking statements whether as a result of new information, future events or otherwise.

Such factors include, among others, risks related to: the completion of the potential transaction with CopAur Minerals Inc. for the purchase of the Company's remaining participating interest in the Kinsley Mountain Gold Project joint venture; reliance on technical information provided by third parties on any of our exploration properties; changes in project parameters as plans continue to be refined; current economic conditions; future prices of commodities; possible variations in grade or recovery rates; failure of equipment or processes to operate as anticipated; the failure of contracted parties to perform; labor disputes and other risks of the mining industry; delays due to pandemic; delays in obtaining governmental approvals, financing or in the completion of exploration, as well as those factors discussed in the section entitled "Risk Factors" in the Company's Management Discussion and Analysis for the Six Months Ending March 31 , 2024, which is available under Company's SEDAR profile at www.sedar.com .

Although Nevada Sunrise has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Nevada Sunrise disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise. Accordingly, readers should not place undue reliance on forward-looking information.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE Nevada Sunrise Metals Corporation

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/July2024/08/c5338.html

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QX Resources Ltd Large Basin Confirmed in Drillholes at Liberty Lithium Brine

Perth, Australia (ABN Newswire) - QX Resources Limited (ASX:QXR) can confirm that the Liberty Lithium brine project in California, USA, is a large brine basin with numerous brine aquifers, shown in downhole sampling and geophysics in the second hole of the Company's two-hole diamond drill program (Table 1*).

- Drilling and geophysics indicate the existence of a large brine basin at Liberty Lithium Brine Project USA, with brine intersected over 400 m vertically.

o Geological similarities confirmed with the nearby Silver Peak lithium brine producer Albemarle, in Clayton Valley Nevada, with encouraging initial lithium assay results, aquifers and salinity.

- Lithium brine specialists have proposed additional drilling to intersect deep lithium brines in the centre of the basin, in a more favourable setting, further west of recent drilling.

- Discussions continue with various USA based battery supply participants who are keen to work with potential new lithium developers within the USA, including with Stardust who aim to IPO in June.

- QXR and IG Lithium Option Agreements are being amended to facilitate undertaking further drilling.

- QXR aims to provide an update soon on progress with gold exploration in Queensland.

Porous conglomerates saturated with brines were intersected beneath fine grained lake sediments with sandy layers. The geology intersected is very encouraging as it is similar to the producing sequences of Clayton Valley Nevada, where Albemarle's producing lithium brine deposit is located. Detailed downhole geophysics together with initial downhole brine sampling (packer sampling) shows increasing salinity with depth, together with large brine volumes, both encouraging for discovering a potentially economic lithium brine deposit in the properties.

Although the maximum lithium assay values were 50mg/l Li over 15 metres near the base of hole #2 (Table 2*), the salinity and conductivity increased with depth, at levels similar to known producers. Ingress of fresh water into the aquifers may explain the lower lithium values in drill holes #1 and #2 being located close to a range front fault on the edge of the basin. These initial holes were located near the edge of the basin in part for logistics and access reasons as well as the surface lithium anomaly.

Hole #2 also intersected thick porous brine horizons - critical for future success- which is considered encouraging, together with the geological similarity to Clayton Valley NV (Albemarle's Silver Peak mine). These similarities include basal porous conglomerate units containing brine beneath finer grained lake sediments.

However, the best producing horizons at Clayton Valley are tuff units within the sediment package which have not been intersected in drillholes to date, but which outcrop 4km to the southwest of hole #2 (Figure 4*).

Results were analysed by external lithium brine specialists to produce interpretations, including the globally recognised Hydrominex Geoscience Consulting. Lithium brine specialists have advised additional drilling is required to potentially intersect deep lithium brines in the centre of the basin, further west of drilling undertaken by QXR, based on lab results to date.

QXR Managing Director, Stephen Promnitz, said: "QXR has defined a new large scale brine basin, saturated with brines, at the Liberty Lithium Brine Project. A large near-surface brine field with lithium potential is rare to date in the USA. The geological setting, with conglomerates loaded with brines, is similar to Albemarle's producing deposit. We are yet to find tuff horizons similar to Clayton Valley, which are the best brine aquifers - although they do outcrop nearby, suggesting they may exist within the basin. Surface and downhole geophysics make it compelling for further drilling to the west, in the centre of the basin under deeper sediments, which may intersect higher grade lithium brine, compared to the drilling to date."

Next Steps

Applications for further drillholes were submitted some time ago. To provide operational flexibility, an amended drill program has been submitted to regulators for approval. Bulk volumes of brine will be submitted for testwork with selected direct lithium extraction (DLE) providers, as well as with lithium refiner Stardust Power Inc, with whom QXR holds at Letter of Intent (ASX announcement 29 Feb 2024). Stardust expects to list on NASDAQ in June via a c.US$490m deal and then plans to build a lithium refinery in Oklahoma.

Discussions continue with various USA based battery supply participants who are keen to work with potential new lithium developers within the USA.

QXR and IG Lithium are currently discussing amendments to the Option Agreements to facilitate the undertaking of further drilling.

Background

The Liberty Lithium Brine Project, located in SaltFire Flat, California, covers contiguous claims over 102km2 (25,300 acres), being one of the largest single lithium brine projects in the USA (Figure 1*). The Company entered an Option to Purchase Agreement and an Operating Agreement (Option Agreements) to earn a 75% interest in the large scale Liberty Lithium brine project in California, USA, from vendor IG Lithium LLC (ASX announcement 5 October 2023). Based on results received to date, the Company is currently in discussion with IG Lithium regarding potential renegotiation of the Option Agreements to allow a longer period of time to conduct additional drilling prior to any future commitments.

Two vertical diamond drill holes were completed (369m & 443 metres depth), spaced 4km apart (Figure 2, 3*).

Holes were centred over an extensive lithium brine surface anomaly and significant MT geophysical target, interpreted as a series of conductive brine bearing aquifers at depth. Brine horizons were intersected in both holes with numerous brine aquifers intersected in drillhole #2 (ASX announcement 8 Feb 2024).

QXR entered into a Letter of Intent with Stardust Power Inc., a development stage American manufacturer of battery-grade lithium products, to assess the lithium brines from the Liberty Lithium Brine Project. The parties intend to evaluate options to potentially supply Stardust Power with lithium brine products, dependent on results, on a non-exclusive basis for processing into battery-grade lithium materials for electric vehicles (ASX announcement 29 Feb 2024). The Company plans to share the results of the two hole drill program with Stardust as part of ongoing discussions.

Drillholes

Drillhole #1 (LLD23001) was completed at 369 metres depth. Target horizons were intersected at 49m depth and 329m depth. Fine grained sediments, gravels and coarse alluvial fan material were intersected down the length of the hole. An interpretation is that the drillhole went through the range front fault at 249m depth.

Drillhole #2 (LLD24002) was completed at 433 metres depth, located 4km to the south of drillhole #1. Both drillholes were centred over significant MT geophysical targets interpreted as a series of conductive brine bearing aquifers at depth. Both holes were positioned within an extensive lithium brine surface anomaly of over 10km defined in auger samples. An interpretation is that the drillhole went through the range front fault at 370m depth.

Figures 5 shows the increase in lithium and chloride concentration in brine with increasing depth. Figures 6-8* show interpretations of the possible geology on MT geophysical lines and the location of proposed drill holes.

The location of the proposed drill holes is also shown in Figure 9*.

Recommendations

Results were analysed by external lithium brine specialists to produce interpretations, including the globally recognised Hydrominex Geoscience Consulting, and others who have closely reviewed the geological setting of Albemarle's Silver Peak lithium brine producer in Clayton Valley, Nevada. Their recommendations included additional drilling further west of drilling undertaken by QXR, to potentially intersect deep lithium brines in the centre of the basin, based on lab results to date. Surface and downhole geophysics suggests that the basin is angled to the west with deeper sediments and brines to the west of recent drilling. Further, the geochemistry of the brine samples may suggest an ingress of fresh water into the aquifers, resulting in lower lithium grade in the two holes drilled to date, as the holes were drilled adjacent to a range front fault with significant fresh water inflows into the basin, along the basin edge.

*To view tables and figures, please visit:
https://abnnewswire.net/lnk/C58T0H5U

About QX Resources Ltd:

QX Resources Limited (ASX:QXR) is focused on exploration and development of battery minerals, with hard rock lithium assets in a prime location of Western Australia (WA), and gold assets in Queensland. The aim is to connect end users (battery, cathode and car makers) with QXR, an experienced explorer/developer of battery minerals, with an expanding mineral exploration project portfolio and solid financial support.

Lithium portfolio: QXR's lithium strategy is centred around WA's prolific Pilbara province, where it has acquired a controlling interest in four projects through targeted M&A - all of which sit in strategic proximity to some of Australia's largest lithium deposits and mines. Across the Pilbara, QXR's regional lithium tenement package (both granted or under application) now spans more than 350 km2.

Gold portfolio: QXR is also developing two Central Queensland gold projects - Lucky Break and Belyando - through an earn-in agreement with Zamia Resources Pty Ltd. Both gold projects are strategically located within the Drummond Basin, a region that has a >6.5moz gold endowment.

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Top 5 NASDAQ Pharma Stocks of 2024

Today's pharmaceutical market is facing the challenges of inflation, government-imposed drug price caps and waning demand for COVID-19 vaccines. However, the industry's major underlying drivers — higher rates of cancer and chronic diseases — are still at play.

The US reigns supreme in the pharma market, both in terms of drug demand and development. Last year, 55 novel medicines were approved by the US Food and Drug Administration (FDA), compared to 37 such approvals for all of 2022. As of mid-July, 22 novel medicines have received FDA approval in 2024, including Eli Lilly's (NYSE:LLY) Alzheimer's disease treatment Kisunla (donanemab-azbt). Big Pharma has largely stole the show throughout the course of this year, but a number of small- and mid-cap NASDAQ pharma stocks also made gains in 2024.

Below the Investing News Network profiles the five top NASDAQ pharma stocks by share price performance so far this year. Data was compiled on July 12, 2024, using TradingView’s stock screener, and all companies listed had market caps between US$50 million and US$500 million at that time. Read on to learn more about their activities this past year.

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Principal Technologies Announces Extension of Private Placement Closing Date

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All securities issued to the Offering will be subject to a statutory four-month hold period. The closing of the second tranche of the Offering will be subject to a number of conditions, including without limitation, approval of the TSXV.

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Cardiol Therapeutics Reports Results of 2024 Annual General and Special Meeting of Shareholders

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces the results from its annual general and special meeting of shareholders (the "Meeting") held virtually via live audio webcast, on June 26, 2024. Shareholders voted in favour of all management resolutions proposed in the Company's management information circular dated May 13, 2024.

Resolutions proposed and approved at the Meeting were:

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Principal Technologies Announces Extension of Private Placement Closing Date

Principal Technologies Inc. (the "Company") (TSXV: PTEC; FSE: J07), announces that it has received an extension from the TSX Venture Exchange with respect to the duration of its previously announced private placement (the "Private Placement") (see the Company's press releases dated April 3, 2024; June 7, 2024; and June 20, 2024), and intends to close a second and final tranche of the Private Placement on or before July 15, 2024.

ON BEHALF OF THE BOARD

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Nominees	Number of Shares For	Percentage of Votes Cast
David Elsley	17,994,588	99.66%
Peter Pekos	17,336,814	96.01%
Dr. Guillermo Torre-Amione	17,345,669	96.07%
Colin Stott	17,349,964	96.09%
Michael Willner	17,348,726	96.08%
Jennifer Chao	17,346,733	96.07%
Chris Waddick	17,352,587	96.10%
Teri Loxam	17,348,275	96.08%

Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution , 100 mg/mL due to Crystallization

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